BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 7118994 · Received December 14, 2017

    Report

    Report Number
    2023826-2017-01865
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    September 8, 2017
    Report Date
    November 15, 2017
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00841542103640
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WORK ORDER SEARCH: NO SIMILAR COMPLAINTS TYPES EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: PRODUCT EVALUATION FOUND THAT THE LENS WAS RETURNED TAPED TO AN EMPTY CARTRIDGE CASE. VISUAL INSPECTION FOUND DEBRIS ON LENS AND THE HAPTIC MISSING A PIECE. (B)(4). THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7 MM MICL13.7, -14.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, NARROWING OF THE ANGLE, AND SHALLOWING OF THE ACD. THE LENS WAS EXCHANGED FOR SHORTER LENS AND THE PROBLEM WAS RESOLVED. (B)(4). CONCLUSION CODE: - PER DFU FOR THIS LENS MODEL, IT IS RECOMMENDED ONLY TO USE MICROSTAAR INJECTORS, MODEL MSI-TF OR MSI-PF WITH SFC-45 OR SFC-45 FP CARTRIDGE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL13.7, -14.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO DECREASE VISUAL ACUITY. AT THE TIME OF SUBMISSION, ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895816 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.7 N/A 00841542103640

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention